Regulatory Affairs Manager - Freelancer(m/w/x)

# Regulatory Affairs Manager - Freelancer (m/f/d) **Vienna** | **Part time** **Here's what we're looking for:** *Part Time Freelancer (Vienna) - 25-30 hrs/week* We are looking for a **Regulatory Manager Freelancer** with experience in the area of Medical Device regulations. Our software apps are updated every other week thereby requiring lean and effective regulatory processes. As we are often pioneers in our field, we need a pragmatic person who is eager to expand into new fields of products and services. mySugr currently has class IIa and IIb products on the market and is ISO13485, MDR and MDSAP certified; as a Regulatory Manager Freelancer you will support our product development activities and ensure regulatory compliance. **Essential skills for your mission:** * More than 5 years professional experience with current EU and/or FDA Medical Device regulations and guidelines * Professional experience with ISO standards for Quality Management, Risk Management and Software development * Professional experience with class IIa, IIb and/or 510k Medical Device registrations * Experience in audits by Authorities and/or notified bodies * Experience in working on overlapping projects - i.e. good at juggling multiple projects, multitasking and organizing yourself * Experience in optimising existing processes to work for multiple regulatory jurisdictions and at the same time minimising impact on daily work as far as possible * Excellent written and verbal communication skills in English * Enjoy learning new things * Willingness to working in cross functional, fast-paced corporations **Bonus skills:** * Knowledge of the diabetes industry or other comparable health industries * Technical understanding and love for innovative apps or software development * Experience working in agile environments **What to expect:** * Ambitious and passionate people building meaningful products for a global audience * An innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams * A growing organization with room for development **Who we are and what we care about?** We are committed to providing a healthy, equal and inclusive working environment for our employees to bring true relief to the patient! We care about family friendly career paths, sustainability, a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing, as well as open and candid feedback. At every level, there are many opportunities to develop and grow - both professionally and personally. As a healthcare pioneer committed to transforming the lives of billions of people around the globe, we push boundaries to redefine what is possible. We know that early, accurate diagnosis is essential to maintain health, prevent disease and help advance new, targeted treatments and potential cures for the world’s most serious health problems. We have a passion for innovation and a profound commitment to make a lasting impact on society by continuing to improve the standard of care for humankind. Our culture inspires us to create healthcare that is sustainable, efficient and financially viable. Healthcare that is built on people’s needs, strong data and clinical insights. Healthcare that saves lives. **Roche is an Equal Opportunity Employer.**